No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817274020869 | AST2-125 | AST LIQUID (2x 125mL) | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | JAS Diagnostics | |
2 | 00817274022764 | MAG2-125 | MAG2-125 | Magnesium Arsenazolk Liquid (2 x 125 mL) | JGJ | Photometric Method, Magnesium | 1 | JAS Diagnostics, inc |
3 | 00817274022658 | XL-MAG2-40 | XL-MAG2-40 | Magnesium Arsenazo (5 x 40mL) | JGJ | Photometric Method, Magnesium | 1 | JAS Diagnostics, inc |
4 | 00817274022504 | MAG2A-BUL | MAG2A-BUL | Magnesium Arsenazo Bulk Liquid (Carolina) | JGJ | Photometric Method, Magnesium | 1 | JAS Diagnostics, inc |
5 | 00817274022405 | MAGS-BUL | MAGS-BUL | Magnesium Standard Liquid Bulk | JGJ | Photometric Method, Magnesium | 1 | JAS Diagnostics, inc |
6 | 00817274022399 | MAG2-BUL | MAG2-BUL | Magnesium Arsenazo Bulk Liquid (20L) | JGJ | Photometric Method, Magnesium | 1 | JAS Diagnostics, inc |
7 | 00817274021958 | TBN2-125 | TOTAL BILI LIQUID (2x 125mL R1, 1x 5mL Sodium Nitrite) | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
8 | 00817274021941 | DG-TBN2/BID2-125 | TOTAL BILI LIQUID (1x 125mL), DIRECT BILIRUBIN (1x 125mL), 1x 5mL Sodium Nitrite. | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
9 | 00817274021934 | BIN2-BUL | SODIUM NITRITE BULK LIQUID | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
10 | 00817274022108 | TRIS-3U | TRIGLYCERIDES STANDARD (1x 3mL) Unlabeled Vial | JIX | Calibrator, Multi-Analyte Mixture | 2 | JAS Diagnostics | |
11 | 00817274022092 | XL-TRI2-40 | TRIGLYCERIDES REAGENT LIQ (5x 40mL) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
12 | 00817274022085 | TRI2-125 | TRIGLYCERIDES REAGENT LIQ (2x 125mL) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
13 | 00817274022078 | TRI2-1LU | TRIGLYCERIDES LIQUID REAGENT (1x 1L) Unlabeled Vial | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
14 | 00817274021927 | BIN2-5U | SODIUM NITRITE (1x 5mL) UNLABELED VIAL | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
15 | 00817274022061 | TRI2-1L | TRIGLYCERIDES LIQUID REAGENT (1x 1L) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
16 | 00817274022054 | TRI2-125U | TRIGLYCERIDES LIQUID REAGENT (1x 125mL) Unlabeled Vial | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
17 | 00817274021910 | XL-PHO2-40 | PHOSPHORUS REAGENT (5 x40 mL) | CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | JAS Diagnostics | |
18 | 00817274022047 | DG-TRI2-125 | TRIGLYCERIDES LIQUID (2x 125mL + 1x 3mL Standard) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
19 | 00817274022030 | DG-TRI2-1L | TRIGLYCERIDES LIQUID (1 x 1 Liter + 1 x 5 mL Standard) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics | |
20 | 00817274022023 | TPT2-BUL | TOTAL PROTEIN LIQUID REAGENT Bulk | CEK | Biuret (Colorimetric), Total Protein | 2 | JAS Diagnostics | |
21 | 00817274022016 | XL-TPT2-40 | TOTAL PROTEIN (5x 40mL) | CEK | Biuret (Colorimetric), Total Protein | 2 | JAS Diagnostics | |
22 | 00817274022009 | TPT2-125 | TOTAL PROTEIN (2x 125mL | CEK | Biuret (Colorimetric), Total Protein | 2 | JAS Diagnostics | |
23 | 00817274021996 | TPT2-125U | TOTAL PROTEIN (1x 125mL) Unlabeled Vial | CEK | Biuret (Colorimetric), Total Protein | 2 | JAS Diagnostics | |
24 | 00817274021989 | XL-TBN2-40 | TOTAL BILIRUBIN LIQUID (4x 40mL R1, 1x 5mL Sodium Nitrite) | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
25 | 00817274021972 | TBN2-BUL | TOTAL BILIRUBIN BULK LIQUID | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
26 | 00817274022795 | MIAC2-7 | MIAC2-7 | Microalbumin Control Kit (L1 & L2) | DCF | Albumin, Antigen, Antiserum, Control | 2 | JAS Diagnostics |
27 | 00817274022856 | HDL4-250 | HDL4-250 | HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | JAS Diagnostics |
28 | 00817274022849 | AMY2-BUL | AMY2-BUL | AMYLASE BULK LIQUID | JFJ | Catalytic Methods, Amylase | 2 | JAS Diagnostics |
29 | 00817274022832 | GLU2-125 | GLU2-125 | GLUCOSE HEXOKINASE (2 x 125mL) | CGA | Glucose Oxidase, Glucose | 2 | JAS Diagnostics |
30 | 00817274021965 | TBN2-125U | TOTAL BILIRUBIN (125mL) UV | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics | |
31 | 00817274022825 | MICS-10 | MICS-10 | Microprotein Standard (1 x 10 mL) | JIX | Calibrator, Multi-Analyte Mixture | 2 | JAS Diagnostics |
32 | 00817274022818 | MICS-15 | MICS-15 | Microprotein Standard | JIX | Calibrator, Multi-Analyte Mixture | 2 | JAS Diagnostics |
33 | 00817274022801 | MIAS-1 | MIAS-1 | Microalbumin Multi-Calibrator (Levels A-F) | JIT | Calibrator, Secondary | 2 | JAS Diagnostics |
34 | 00817274022788 | MIA2-20 | MIA2-20 | Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL) | DCF | Albumin, Antigen, Antiserum, Control | 2 | JAS Diagnostics |
35 | 00817274022771 | AMY2-P1L | AMY2-P1L | AMYLASE Powder PALS (1 x1L) | JFJ | Catalytic Methods, Amylase | 2 | JAS Diagnostics |
36 | 00817274022702 | CHOS-1L | CHOS-1L | CHOLESTEROL STD (1 X 1L) | JIT | Calibrator, Secondary | 2 | JAS Diagnostics |
37 | 00817274022696 | ALBS-1L | ALBS-1L | ALBUMIN STANDARD (1x 1L) | CIX | Bromcresol Green Dye-Binding, Albumin | 2 | JAS Diagnostics |
38 | 00817274022672 | BUNS-1L | BUNS-1L | UREA NITROGEN STANDARD (1x 1L) | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | JAS Diagnostics |
39 | 00817274022641 | LIPS1-3U | LIPS1-3U | LIPID CALIBRATOR (1 x 3 mL) UV | JIT | Calibrator, Secondary | 2 | JAS Diagnostics |
40 | 00817274022634 | LIPS1-3 | LIPS1-3 | LIPID CALIBRATOR (1 x 3 mL) | JIT | Calibrator, Secondary | 2 | JAS Diagnostics |
41 | 00817274022627 | J0001C | J0001C | OLYMPUS WASH SOLUTION - CONCENTRATE (6 x 2L) | JCB | Detergent | 1 | JAS Diagnostics |
42 | 00817274022139 | URI2-125 | URIC ACID LIQ (2x 125mL) | KNK | Acid, Uric, Uricase (Colorimetric) | 1 | JAS Diagnostics | |
43 | 00817274021699 | HDL4-BUL | HDL CHOLESTEROL Bulk | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | JAS Diagnostics | |
44 | 00817274022597 | LDL4-30 | LDL4-30 | LDL, (2 x 30 mL R1, 2 x 10mL R2) | JHM | Colorimetric Method, Lipoproteins | 1 | JAS Diagnostics |
45 | 00817274022580 | IRO2-125 | IRO2-125 | Iron Liquid Reagent (2 x 125 mL R1, 1 x 15 mL R2) | JIY | Photometric Method, Iron (Non-Heme) | 1 | JAS Diagnostics |
46 | 00817274022566 | TPTS-3U | TPTS-3U | TOTAL PROTEIN STANDARD (3mL) | CEK | Biuret (Colorimetric), Total Protein | 2 | JAS Diagnostics |
47 | 00817274022559 | CAAS-1L | CAAS-1L | CALCIUM Standard (1 x 1L) | CIC | Cresolphthalein Complexone, Calcium | 2 | JAS Diagnostics |
48 | 00817274022542 | GLU2-1L | GLU2-1L | GLUCOSE HEXOKINASE (1 x 1L) | CGA | Glucose Oxidase, Glucose | 2 | JAS Diagnostics |
49 | 00817274022535 | TRI2-BUP | TRI2-BUP | Triglycerides Powder Bulk (20L) | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | JAS Diagnostics |
50 | 00817274022528 | TBN2-1L | TBN2-1L | TOTAL BILIRUBIN LIQUID (1 x 1L R1, 1 X 15 mL Sodium Nitrite) | CIG | Diazo Colorimetry, Bilirubin | 2 | JAS Diagnostics |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 17350066140579 | 660-20 | AMH Control | FUJIREBIO DIAGNOSTICS AB | ||
2 | 17350066140531 | 240-20 | Lung Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
3 | 17350066140524 | 360-20 | Mesothelin Control | FUJIREBIO DIAGNOSTICS AB | ||
4 | 17350066140043 | 108-20 | Tumor Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
5 | 17290018739072 | FG00004 | The Performance Verification Kit contains a set of serum-based quantitative samp The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. | Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP | MEMED DIAGNOSTICS LTD | |
6 | 15099590233877 | 657365 | 657365 | SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum | Synchron | BECKMAN COULTER, INC. |
7 | 15099590228743 | 465939 | 465939 | SYNCHRON Systems 125 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
8 | 15099590227357 | 450163 | 450163 | Vigil Serology Control Level 2 | Vigil | BECKMAN COULTER, INC. |
9 | 15099590227333 | 450164 | 450164 | Vigil Serology Control Level 3 | Vigil | BECKMAN COULTER, INC. |
10 | 15099590227326 | 465440 | 465440 | Vigil Serology Control Level C | Vigil | BECKMAN COULTER, INC. |
11 | 15099590227258 | 465912 | 465912 | SYNCHRON Systems 75 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
12 | 15099590227234 | 465914 | 465914 | SYNCHRON Systems 20 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
13 | 15099590226916 | 450120 | 450120 | Vigil Protein Control Level 1 | Vigil | BECKMAN COULTER, INC. |
14 | 15099590225384 | 465290 | 465290 | Immunochemistry Systems Level 1 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
15 | 15099590224158 | 465300 | 465300 | Immunochemistry Systems Level 2 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
16 | 15099590223045 | 450125 | 450125 | Vigil Protein Control Level 2 | Vigil | BECKMAN COULTER, INC. |
17 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | Vigil | BECKMAN COULTER, INC. |
18 | 15099590222918 | 465981 | 465981 | Vigil Lipid Control Level 3 | Vigil | BECKMAN COULTER, INC. |
19 | 15099590222901 | 465982 | 465982 | Vigil Lipid Control Level 4 | Vigil | BECKMAN COULTER, INC. |
20 | 15099590222611 | 450130 | 450130 | Vigil Protein Control Level 3 | Vigil | BECKMAN COULTER, INC. |
21 | 15099590222604 | 450162 | 450162 | Vigil Serology Control Level 1 | Vigil | BECKMAN COULTER, INC. |
22 | 15099590222000 | 474988 | 474988 | SYNCHRON Systems OP 300 Low Urine Control | Synchron | BECKMAN COULTER, INC. |
23 | 15099590221997 | 474991 | 474991 | SYNCHRON Systems OP 300 High Urine Control | Synchron | BECKMAN COULTER, INC. |
24 | 15099590221270 | 469905 | 469905 | Vigil Lipid Control Level 1 | Vigil | BECKMAN COULTER, INC. |
25 | 10851290002567 | CVC 223 | CVC 223 | RNA Medical CVC 223 Multi-Level Carton | RNA Medical | RNA MEDICAL DIVISION |
26 | 10851290002550 | CVC 123 | CVC 123 | Carton for CVC 123 | RNA Medical | RNA MEDICAL DIVISION |
27 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
28 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
29 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
30 | 10758750008322 | 1009406 | 1009406 | VITROS Immunodiagnostic Products RE Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
31 | 10758750006977 | 6801751 | 6801751 | VITROS Chemistry Products %A1c Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
32 | 10758750006960 | 6801750 | 6801750 | VITROS Chemistry Products %A1c Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
33 | 10758750002702 | 6802349 | 6802349 | VITROS Chemistry Products dTIBC Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
34 | 10758750002696 | 6802348 | 6802348 | VITROS Chemistry Products dTIBC Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
35 | 10627966005305 | C5003-2 | C5003-2 | RAMP® Cardiac Controls - Level 2 | RESPONSE BIOMEDICAL CORP | |
36 | 10627966005299 | C5003-1 | C5003-1 | RAMP® Cardiac Controls - Level 1 | RESPONSE BIOMEDICAL CORP | |
37 | M52551410 | 5141 | Hi Res Protein Marker | HELENA LABORATORIES CORPORATION | ||
38 | M52551360 | 5136 | SPE Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
39 | M52550690 | 5069 | LipoTrol (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
40 | M52534250 | 3425 | SPE Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
41 | M52534240 | 3424 | SPE Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
42 | M52518110 | 1811 | V8 SP Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
43 | M52518100 | 1810 | V8 SP Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
44 | M52518050 | 1805 | V8 Serum Protein SPE Kit (500 tests) | HELENA LABORATORIES CORPORATION | ||
45 | M52514790 | 1479 | Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays | HELENA LABORATORIES CORPORATION | ||
46 | 08718734961499 | Level 3 | 221.003.010 | CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
47 | 08718734961482 | Level 2 | 221.002.010 | CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
48 | 08718734961475 | Level 1 | 221.001.010 | CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
49 | 08718734961468 | 220.000.005 | CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 | CueSee® VeriSTAT LVM | EUROTROL B.V. | |
50 | 08718734960928 | 183.000.005 | Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. | Eurotrol | EUROTROL B.V. |